Frontier V4 AWD or FWD
Frontier V4 AWD or FWD (EIMM) is a wheelchair recliner (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Sunrise Medical (US) LLC, cleared under FDA 510(k) K213090 on 19 Nov 2021 and listed in FDA GUDID since 5 Sep 2023 (UDI-DI 00016958059717), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00016958059717 | Date5 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213090 | Date19 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 00016958059717
- FDA 510(k) database K213090
Across registries
- FDA 510(k) K213090 decided 19 Nov 2021 Active
- FDA GUDID UDI-DI 00016958059717 listed 5 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K213090
- Listed FDA GUDID 00016958059717
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Frontier V4
- Generic name
- Wheelchair recliner, battery-powered
- Model / Ref / Catalog
- Frontier V4 AWD or FWD, EIMM
- Primary DI / UDI-DI
- 00016958059717
- 510(k) Number
- FDA product code
- ITI
- GMDN term
- Wheelchair recliner, battery-powered
- Device class
- Class II
- Regulation number
- 890.3860
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ITI (Wheelchair, Powered).
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- MP3U, POWER WHEELCHAIR by MERITS HEALTH PRODUCTS., INC.
- TEKNIQUE by Hoveround Corp.
- Electric Wheelchair (0080) by Xuzhou Heabens Medical Technology Co., LTD.
- CHILD'S ROLLS POWERED WHEELCHAIR by Invacare Corp.
- FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 by Teftec Corp.
- JAGUAR by Inacare Corp.
- STREET by PERMOBIL, INC.